Label: information for the user

normonasal 0.5 mg/ml nasal spray solution

Oxymetazoline hydrochloride

Read this label carefully before starting to use this medication, as it contains important information for you.

Follow exactly the medication administration instructions contained in this label or those indicated by your doctor or pharmacist.

or your pharmacist.

• Keep this label, as you may need to refer to it again.
• For advice on any matter relating to this medicine or for information about any of the possible side effects, consult your pharmacist.
• Consult a doctor, pharmacist or nurse if you experience any side effects, even if they do not appear in this label. See section 4.
• You should consult a doctor if your symptoms worsen or do not improve after 3 days.

6. Contents of the pack and additional information

This medication belongs to a group of medications called sympathomimetics. It is a nasal decongestant medication that contains oxymetazoline as the active ingredient. When

oxymetazoline is administered through the nose, it causes constriction of the blood vessels at the local level, thereby decongesting the nasal mucosa.

It is indicated for the local and temporary relief of nasal congestion in adults and children over 6 years old.

Consult a doctor if symptoms worsen or do not improve after 3 days of treatment.

No use normonasal

• If you are allergic to oxymetazoline, other nasal decongestants, or any of the other components of this medication (listed in section 6).
• If you have recently undergone surgery on your head (if you have undergone any cranial, transnasal, or transoral surgical intervention).

Warnings and precautions

Consult your doctor or pharmacist before starting to use normonasal if:

• You are being treated with antidepressant medications, phenothiazine (tranquilizer), or methyldopa (to lower blood pressure).
• You have experienced or are experiencing any of the following diseases or symptoms, even if it only occurred once:

• If you have high blood sugar levels (diabetes mellitus)
• If you have high blood pressure (hypertension)
• If you have any heart or circulatory system disease
• If you have an enlarged prostate with difficulty urinating (hypertrophic prostate)

prostate)

• If you have any thyroid disease (hyperthyroidism)

• If you have ever experienced insomnia or dizziness when taking other

medicines that stimulate the sympathetic nervous system, such as those used to treat heart disease, low blood pressure, or asthma.

In rare cases, oxymetazoline, due to its temporary effects and prolonged use,

may increase nasal congestion instead of reducing it; this is known as rebound effect.

Rarely, insomnia may occur after using the medication. If this happens to you

avoid using it in the late afternoon or at night.

Do not exceed the recommended dose in section 3. How to use normonasal.

To avoid contagion, the medication should not be used by more than one person and the applicator

should be cleaned with a clean, damp cloth after each use.

Children

Do not use in children under 6 years old.

Children may be especially prone to the appearance of adverse effects of this

medication.

Use of normonasal with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

This medication should not be used by people taking or having taken during the last 2 weeks: medications used to treat depression (tricyclic antidepressants or monoamine oxidase inhibitors (MAOIs), or a medication to lower blood pressure called methyldopa.

It should also not be used while being treated with phenothiazine (tranquilizer) or with

medications to treat asthma.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant or intend to become pregnant, consult your doctor or pharmacist before using a medication.

This medication should not be used during pregnancy or breastfeeding.

Driving and operating machinery

Although problems are not expected, if you experience drowsiness or dizziness, do not drive or operate hazardous tools or machinery.

Normonasal contains benzalkonium chloride

This medication contains 0.216 mg of benzalkonium chloride in each ml.

Benzalkonium chloride may cause irritation or inflammation inside the nose, especially when used during long-term treatment.

Follow exactly the administration instructions of the medication contained in this leaflet or those indicated by your doctor or pharmacist. In case of doubt, ask your doctor or pharmacist.

The recommended dose is:

Adults and children aged 6-12 years

2-3 sprays in each nostril no more than 2 times in 24 hours.

Use in children

Children under 6 years: This medication should not be used in children under 6 years.

Over 65 years

Consult your doctor or pharmacist since older people are more sensitive to the adverse effects of this medication.

How to use

This medication is used by nasal route.

If it is the first time this product is used or it has not been used for a long time, it is necessary to prime the sprayer. To do this, keeping the container away from the body, press the sprayer several times until the finely pulverized liquid comes out.

Before applying this medication, you must eliminate existing nasal secretions, blowing your nose well.

Perform the pulsation in a rapid and firm manner, in each nostril keeping the head

raised and inhaling deeply while pressing the sprayer.

To avoid contagions, after each use and before closing the container, the tip of the applicator must be cleaned with a clean and damp cloth. In addition, each container must be used only by 1 person.

If it worsens or does not improve after 3 days of treatment, interrupt the treatment and

consult your doctor.

If you use more normonasal than you should

By excessive or very frequent dose application, you may notice: Headache, tremors,

insomnia, excessive sweating, palpitations, tachycardia, increased blood pressure or

sleep disturbances.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91.5620420, indicating the medication and the amount ingested.

Like all medications, normonasal can produce adverse effects, although not all people experience them.

During the period of use of oxymetazoline, the following adverse effects have been observed, whose frequency has not been established with precision:

The adverse effects that have occurred most frequently are:

Itching at the application site, dryness, nasal mucosa itching or sneezing.

The adverse effects that may occur in rare cases are:

Anxiety, restlessness, insomnia, hallucinations, tremors, and sleep disorders in children.

Tachycardia, palpitations, increased blood pressure. Headache, nausea, exanthema (skin redness).

Excessive or continued use of this medication may lead to nasal congestion.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is about possible adverse effects that do not appear in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use (Website: www.notificaRAM.es).

By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Keep this medication out of the sight and reach of children.

Store below 25°C.

Do not use this medication after the expiration date that appears on the packaging after

CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and

medicines you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. By doing so, you will help protect the environment.

Composition of normonasal

The active ingredient is oxymetazoline. Each ml contains 0.5 mg of oxymetazoline, as the active ingredient.

The other components (excipients) are benzalkonium chloride, sodium monobasic phosphate anhydrous, sodium chloride, sodium dibasic phosphate, eucalyptol, menthol, and purified water.

Appearance of the product and contents of the packaging

Normonasal is an incolor and transparent nasal spray solution.

It is presented in polyethylene bottles with a dosing pump containing 15 ml of solution.

Holder of the marketing authorization and responsible for manufacturing:

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6

28760-Tres Cantos-Madrid (SPAIN)

Date of the last review of this leaflet:October 2013

The detailed and updated information of this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/